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TENS Unit for Analgesia During IUD Insertion | Clinical Trials | Clareo Health

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RECRUITINGNANCT06240260

TENS Unit for Analgesia During IUD Insertion

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be...

Lead sponsor: Tufts Medical Center•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Caitie McCarthy, MD

CONTACT

617-636-9897 caitlin.mccarthy@tuftsmedicine.org

Sponsors

Lead Sponsor

Tufts Medical Center

Age

12 - 50 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Persons with a uterus desiring insertion of intrauterine device
•2. Able to provide informed consent/assent
•3. Age 12-50 years old
•4. Minors 12 years of age and older will be included in the study if postmenarchal

Exclusion Criteria

•1. Unable to provide informed consent/assent
•2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
•3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
•4. Cutaneous damage at the TENS electrode sites
•5. Chronic or pre-procedure use of opioids
•6. Chronic pain diagnosis
•7. Prior IUD insertion
•8. Any contraindication to intrauterine device (IUD):
•1. Pregnancy
•2. Uterine anomaly that distorts the uterine cavity
•3. Acute pelvic inflammatory disease (PID)
•4. Postpartum endometritis or infected abortion in the past 3 months
•5. Unexplained abnormal uterine bleeding
•6. Wilson's disease or copper allergy (contraindication to copper IUD only)
•7. Breast cancer (contraindication to levonorgestrel IUD only

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 4, 2025Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment40

Start dateApr 2024

Last updatedJun 4, 2025

Condition

IUD Analgesia Patient Preference Pain, Acute

Locations shown

Tufts Medical Center

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions